Events

Retiro De Equipo (Recall) de HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Werfen Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-01292-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01292-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Vials manufactured prior to june 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. if an affected vial is used with a patient sample, a significant shift in inr greater than 10% could occur with the potential to alter subsequent medical treatment.
  • Acción
    Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.

Device

HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)

Manufacturer

Werfen Australia Pty Ltd